Informed Consent Overview - Module 2 - Health and Biological

I. Process
Federal code states that "[a]ny research project utilizing human subjects requires the informed consent of those subjects." The first step in the process is detailing the specifics of your study that are important to communicate to participants an
d to the IRB.Review of the Informed Consent
Process

Remember that obtaining participant consent is a process.

Potential participants must understand the nature of the study and the risks and benefits involved if they are to make an informed decision about their participation. The details should be presented in simple language by someone who is knowledgeable abou
t both the study and informed consent. This process requires a "consent document" that explains the nature of the research and any risks and benefits to the participant. A copy of the consent document is reviewed by the IRB before it is presented to pro
spective participants. Because informed consent is an ongoing process, it starts before any forms are signed, and it continues until the completion of the subject's involvement in the study. The consent document is only a confirmation of the consent proc
ess. Simple Scenario: Informed Consent Process Flow If the study participants are members of a vulnerable population, more consideration must go into consent document development. Complex Scenario: Informed Consent Process Flow These flowcharts give you an summary of the issues that will require your attention when developing your consent document.

II. Selecting of Participants
Recruitment of participants needs to be done in a nonbiased, non-power-based manner. It is important that none of the participants ever feel that if they do not participate in the study, something will happen to them. Convenience should not be th
e sole factor in the selection of participants. All avenues of recruiting participants should be investigated. The following relationships can be potentially troublesome for informed consent and have important points to be considered.

Doctor/Patient
Doctor-patient relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion. Patients can say no to someone they do not expect to see in the future but it is very difficult for peo
ple to say no when they rely on someone for medical care.

Participants often depend on physicians to make treatment recommendations, and then they just "go along" with the recommendations. They may not read the consent document fully because the physician has already explained the procedure orally, and they con
sider the doctor the primary source for information. This might become a legal situation when the patient does not understand the consent document.

Physicians need to be aware of the complexities of the decision to consent to a research project and be sensitive to the potential for conflict of interest.

Teacher/Student
Special consideration of recruitment is also needed for instances when an instructor wants to include his or her students in a research study. The teacher cannot assume everyone in the class wants to be involved in the study. Students must be assu
red that their grade is not affected by their participation and they should be able to decline participation without penalty. Researchers may fail to identify the need for informed consent if the study is not perceived to have physical or psychological r
isks. Participants, including students, have the right to refuse involvement in a research project even if there is no identified risk.

An additional problem is that researchers may not identify the need for informed consent if the study is not perceived to have physical or mental risks. Participants, including students, have the right to refuse involvement in a research project even if
there is no identified risk.

Employees as participants
Colleagues, subordinates or peers should never be placed in a compromising situation with perceived retribution for not being a research participant. Recruiting through advertisements or a third party are better strategies for avoiding coercion.

Proxy
When a participant is not of legal age or is deemed incompetent to consent to treatment, it is necessary for a proxy (family member, guardian, or friend) to decide consent.

Children
In justifying using children in your study, you must document the specific benefits the child will encounter. A parent or guardian must act as the proxy for the child and complete a parental permission form. Children also need to give their "assent". A
ssent is the affirmative agreement to participate in the study if the child is able to comprehend aspects of the research. You must develop a separate assent form. Try to tailor the assent document to the understanding of the child. Reasonable descript
ions of discomfort should be included. Children can not give consent to research that entails risks that surpass the benefits.

Elderly
Participants that have diminished vision or hearing can often times overcome the problems and consent themselves.

If the person is determined to be incompetent, such as in the case of Alzheimer's disease or other brain diseases, the investigator must seek the consent of a proxy. The proxy may not know the wishes of the participant regarding research studies but shou
ld try to decide in the way the person would have decided. Investigators should ask proxies if they think that participants would have decided in the same manner if they were competent.

In either case, a proxy should discuss the decision with family members and/or the medical staff caring for the person. Even if the participant has been judged incompetent, the person should be considered competent to refuse.

III. Describing the Research
Your participants should be made aware of certain information, including:

Research Purpose: State the purpose of the research and give a fair explanation of your research procedures. Experimental procedures must also be identified.

Duration of Participant Involvement: State the expected duration of the individual's participation (indicate the number of sessions, if more than one).

Participant Qualification: State why the individual is eligible to participate.

Risks: Describe any foreseeable risks or discomforts the subject will bear. Include all reasonably common risks as well as potentially serious risks. Risks may range from inconvenience to bodily pain. Do not overlook "soft" risks such as confi
dentiality and embarrassment. Treatment decisions will always involve a degree of uncertainty regarding the harmful effects. Calculating the probability that these situations will occur can aid in abating the risks; however, the view of the nature of a
risk will vary from participant to participant. Be sensitive to the difficult task of determining if the participant is more of a risk taker, is ignoring the risk(s), or has not adequately understood the probability of the risk(s).

Benefits: Describe any benefits to the participant or others that can reasonably be expected. If there are no benefits, clearly state this. Benefits may range from feeling good about participation to monetary compensation to free access to an
experimental drug. Be careful, however, not to oversell any benefits. Calculate the probability that these beneficial effects will occur. This will aid in determining the weight given to the benefits.

Alternatives: State
alternative procedures or courses of treatment, if any, that might be advantageous to the subject. What are the participant's other options? (In nontherapeutic studies, the alternative may simply be nonparticipation.)

Confidentiality: The informed consent process must describe the level of confidentiality of the research data and the measures that you plan to take to ensure that confidentiality is maintained. Describe the steps that will be taken to protect
the participant's privacy. Include any techniques you may use for identifying data. The most common procedure is that the participant's identity will not be disclosed.

Disclosure of Potential Conflict of Interest:
Researchers must inform their participants of any conflicts of interest they have in the research, such as a stake in a company that might benefit from the research.
Incentives are sometimes offered by companies for recruiting subjects or conducting research on an investigational drug or device. This enticement may be either a monetary fee or a donation of equipment or materials. Researchers must report these incent
ives to the IRB. The IRB might require that prospective participants be made aware of this information.

Compensation to Research Participants: The consent document must describe the terms of any payments used to compensate individuals for their participation. This includes the conditions under which research participants would receive partial paym
ent or no payment at all.
Research-Related Injury: Indicate whether compensation or medical treatments will be available if the participant becomes injured. Include what the compensation/treatment consists of and where further information regarding research-related inju
ry can be obtained (for research involving physical contact or activity).

Contact Information: Give the name(s) of people who can answer questions about the research; include the principal investigator. Furnish the contact name of a neutral third party who can explain the rights of research participants if the partic
ipant has any questions.

Withdrawal: Always stress the fact that participation is voluntary. State that refusing to participate will involve no penalty or decrease in benefits to which the participant is otherwise entitled. Emphasize that the individual may discontinu
e participation at any time without penalty or loss of benefits. If there are limitations to withdrawal, such as a danger to the participant's health, these must also be clearly stated.

IV. Discussing Participation
Informed consent involves educating prospective participants, not merely disclosing information. Providing information is part of the process. The essential elements to be conveyed are discussed in the previous section, "Describing the Research".
Discussions with prospective participants should take place, if possible, prior to the research study - not on the day of the procedure. Participants may need time to think about their decision or to discuss their involvement with family, friends, or re
ligious leaders. When possible, participants should be approached when they are rested and alert, and have access to eyeglasses or hearing devices if necessary.

The process of obtaining consent should include time for both discussion and reflection, as shown in the following steps:

Determine the study concept and components for the document.

Present the prospective participant with the consent document.

Read through the document together, taking time to explain significant or difficult points about the research or participation. Answer any questions. Be certain to discuss risks, benefits, and alternative treatments in addition to purposes and proce
dures.

Allow the participant to read through the document again.

Ask the participant open-ended questions about the nature of the study and participation to make certain he or she understands correctly. (See Assessing Participant Understanding in this module.)

Give the prospective participant a copy of the consent document to
take home and discuss, if desired, with family or friends.

Meet again to clear up any remaining questions. If the participant is willing, have him or her sign
the consent document.

V. Ensuring Readability
Readability of the consent document is an important component of the process. Your consent document information should be presented in non-technical terms at a level that your audience can understand. If your document is not understandable, a leg
al claim could be made that the participant did not understand what was signed. A consent document must be made readable but without compromising the content.

Direct it at an eighth-grade reading level.

Use simple, straightforward sentences.

Use commonly recognizable terms and measurement amounts.

Avoid the use of jargon or technical language, and explain
terms that may not be easily understood.

When you have finished writing the consent document, ask an independent person to read and explain it to you. A reader who has no association with the study can often help you to identify difficult or confusing areas in the document.

Study participants can not be excluded based on language barriers. If you have a participant who does not understand the language of the consent document, you must present a translated consent document or arrange for an interpreter and document the resul
ts.

You will find more information about this subject as you begin to write the consent document in module three.

VI. Assessing Participant
Understanding of the Research
It is your responsibility as a researcher to ensure that prospective participants understand your research. Read through the consent document with them and discuss participation prior to their involvement in your research. During these discussion
s you should answer questions and ask questions, too. Use open-ended and nondirective questions. Open-ended questions often begin with words such as "what," "where," "how often," "when," and "please describe,".

A few of the questions you may want to ask are:

Describe in your own words the purpose of the study.

What more would you like to know?

Would you please explain to me what you think we're going to ask you
to do?

Be certain to prepare the questions you will ask before you meet with the participants. Always answer participant questions fully and truthfully. Patience and encouragement are important when asking and answering questions.